Biomarker testing in non-small cell lung cancer in routine care: Analysis of the first 3,717 patients in the German prospective, observational, nation-wide CRISP Registry (AIO-TRK-0315)

  • Objectives: An increasing number of treatment-determining biomarkers has been identified in non-small cell lung cancer (NSCLC) and molecular testing is recommended to enable optimal individualized treatment. However, data on implementation of these recommendations in the “real-world” setting are scarce. This study presents comprehensive details on the frequency, methodology and results of biomarker testing of advanced NSCLC in Germany. Patients and methods: This analysis included 3,717 patients with advanced NSCLC (2,921 non-squamous; 796 squamous), recruited into the CRISP registry at start of systemic therapy by 150 German sites between December 2015 and June 2019. Evaluated were the molecular biomarkers EGFR, ALK, ROS1, BRAF, KRAS, MET, TP53, RET, HER2, as well as expression of PD-L1. Results: In total, 90.5 % of the patients were tested for biomarkers. Testing rates were 92.2 % (non-squamous), 70.7 % (squamous) and increased from 83.2 % in 2015/16 to 94.2% in 2019. Overall testing rates for EGFR, ALK, ROS1, and BRAF were 72.5 %, 74.5 %, 66.1 %, and 53.0 %, respectively (non-squamous). Testing rates for PD-L1 expression were 64.5 % (non-squamous), and 58.5 % (squamous). The most common testing methods were immunohistochemistry (68.5 % non-squamous, 58.3 % squamous), and next-generation sequencing (38.7 % non-squamous, 14.4 % squamous). Reasons for not testing were insufficient tumor material or lack of guideline recommendations (squamous). No alteration was found in 37.8 % (non-squamous), and 57.9 % (squamous), respectively. Most common alterations in non-squamous tumors (all patients/all patients tested for the respective biomarker): KRAS (17.3 %/39.2 %), TP53 (14.1 %/51.4 %), and EGFR (11.0 %/15.1 %); in squamous tumors: TP53 (7.0 %/69.1 %), MET (1.5 %/11.1 %), and EGFR (1.1 %/4.4 %). Median PFS (non-squamous) was 8.7 months (95 % CI 7.4–10.4) with druggable EGFR mutation, and 8.0 months (95 % CI 3.9–9.2) with druggable ALK alterations. Conclusion: Testing rates in Germany are high nationwide and acceptable in international comparison, but still leave out a significant portion of patients, who could potentially benefit. Thus, specific measures are needed to increase implementation.
Author:Frank GriesingerGND, Wilfried E. E. EberhardtORCiDGND, Arnd NuschGND, Marcel Reiser, Mark-Oliver ZahnGND, Christoph Maintz, Christiane Bernhardt, Christoph LosemGND, Albrecht StenzingerORCiDGND, Lukas HeukampORCiDGND, Reinhard BüttnerORCiDGND, Sebastian MarschnerORCiDGND, Martina JänickeGND, Annette FleitzORCiD, Lisa Spring, Jörg SahlmannORCiDGND, Aysun Karatas, Annette Hipper, Wilko WeichertGND, Monika HeilmannGND, Parvis SadjadianORCiDGND, Wolfgang Gleiber, Christian Grah, Cornelius WallerORCiDGND, Martin ReckORCiDGND, Achim RittmeyerORCiDGND, Petros ChristopoulosORCiDGND, Martin SebastianORCiDGND, Michael ThomasORCiDGND
Parent Title (English):Lung cancer
Place of publication:Amsterdam [u.a.]
Document Type:Article
Date of Publication (online):2020/11/02
Date of first Publication:2020/11/02
Publishing Institution:Universitätsbibliothek Johann Christian Senckenberg
Contributing Corporation:the CRISP Registry Group
Release Date:2023/04/26
Tag:Biomarkers; Cohort studies; Molecular diagnostic testing; Non-small cell lung cancer; Registries
Page Number:13
First Page:174
Last Page:184
The CRISP project is supported by grants from AstraZeneca GmbH, Boehringer Ingelheim Pharma GmbH & Co. KG, Bristol-Myers Squibb GmbH & Co. KGaA, Celgene GmbH, MSD Sharp & Dohme GmbH, Lilly Deutschland GmbH, Novartis Pharma GmbH, Pfizer Pharma GmbH, Roche Pharma AG, and Takeda Pharma Vertriebs GmbH & Co. KG.
Institutes:Medizin / Medizin
Dewey Decimal Classification:6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit
Licence (German):License LogoCreative Commons - Namensnennung-Nicht kommerziell - Keine Bearbeitung 4.0